Minimum clinically important improvement and patient acceptable symptom state in pain and function in rheumatoid arthritis, ankylosing spondylitis, chronic back pain, hand osteoarthritis, and hip and knee osteoarthritis: Results from a prospective multinational study
Objective To estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5 rheumatic diseases and 7 countries. Methods We conducted a multinational (Australia, France, Italy, Lebanon, Morocco, Spain, and The Netherlands) 4...
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Published in | Arthritis care & research (2010) Vol. 64; no. 11; pp. 1699 - 1707 |
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Main Authors | , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Hoboken, USA
John Wiley & Sons, Inc
01.11.2012
Wiley-Blackwell |
Subjects | |
Online Access | Get full text |
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Abstract | Objective
To estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5 rheumatic diseases and 7 countries.
Methods
We conducted a multinational (Australia, France, Italy, Lebanon, Morocco, Spain, and The Netherlands) 4‐week cohort study involving 1,532 patients who were prescribed nonsteroidal antiinflammatory drugs for ankylosing spondylitis, chronic back pain, hand osteoarthritis, hip and/or knee osteoarthritis, or rheumatoid arthritis. The MCII and PASS values were estimated with the 75th percentile approach for 4 generic outcomes: pain, patient global assessment, functional disability, and physician global assessment, all normalized to a 0–100 score.
Results
For the whole sample, the estimated MCII values for absolute change at 4 weeks were −17 (95% confidence interval [95% CI] −18, −15) for pain; −15 (95% CI −16, −14) for patient global assessment; −12 (95% CI −13, −11) for functional disability assessment; and −14 (95% CI −15, −14) for physician global assessment. For the whole sample, the estimated PASS values were 42 (95% CI 40, 44) for pain; 43 (95% CI 41, 45) for patient global assessment; 43 (95% CI 41, 44) for functional disability assessment; and 39 (95% CI 37, 40) for physician global assessment. Estimates were consistent across diseases and countries (for subgroups ≥20 patients).
Conclusion
This work allows for promoting the use of values of MCII (15 of 100 for absolute improvement, 20% for relative improvement) and PASS (40 of 100) in reporting the results of trials of any of the 5 involved rheumatic diseases with pain, patient global assessment, physical function, or physician global assessment used as outcome criteria. |
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AbstractList | Objective
To estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5 rheumatic diseases and 7 countries.
Methods
We conducted a multinational (Australia, France, Italy, Lebanon, Morocco, Spain, and The Netherlands) 4‐week cohort study involving 1,532 patients who were prescribed nonsteroidal antiinflammatory drugs for ankylosing spondylitis, chronic back pain, hand osteoarthritis, hip and/or knee osteoarthritis, or rheumatoid arthritis. The MCII and PASS values were estimated with the 75th percentile approach for 4 generic outcomes: pain, patient global assessment, functional disability, and physician global assessment, all normalized to a 0–100 score.
Results
For the whole sample, the estimated MCII values for absolute change at 4 weeks were −17 (95% confidence interval [95% CI] −18, −15) for pain; −15 (95% CI −16, −14) for patient global assessment; −12 (95% CI −13, −11) for functional disability assessment; and −14 (95% CI −15, −14) for physician global assessment. For the whole sample, the estimated PASS values were 42 (95% CI 40, 44) for pain; 43 (95% CI 41, 45) for patient global assessment; 43 (95% CI 41, 44) for functional disability assessment; and 39 (95% CI 37, 40) for physician global assessment. Estimates were consistent across diseases and countries (for subgroups ≥20 patients).
Conclusion
This work allows for promoting the use of values of MCII (15 of 100 for absolute improvement, 20% for relative improvement) and PASS (40 of 100) in reporting the results of trials of any of the 5 involved rheumatic diseases with pain, patient global assessment, physical function, or physician global assessment used as outcome criteria. Abstract Objective To estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5 rheumatic diseases and 7 countries. Methods We conducted a multinational (Australia, France, Italy, Lebanon, Morocco, Spain, and The Netherlands) 4‐week cohort study involving 1,532 patients who were prescribed nonsteroidal antiinflammatory drugs for ankylosing spondylitis, chronic back pain, hand osteoarthritis, hip and/or knee osteoarthritis, or rheumatoid arthritis. The MCII and PASS values were estimated with the 75th percentile approach for 4 generic outcomes: pain, patient global assessment, functional disability, and physician global assessment, all normalized to a 0–100 score. Results For the whole sample, the estimated MCII values for absolute change at 4 weeks were −17 (95% confidence interval [95% CI] −18, −15) for pain; −15 (95% CI −16, −14) for patient global assessment; −12 (95% CI −13, −11) for functional disability assessment; and −14 (95% CI −15, −14) for physician global assessment. For the whole sample, the estimated PASS values were 42 (95% CI 40, 44) for pain; 43 (95% CI 41, 45) for patient global assessment; 43 (95% CI 41, 44) for functional disability assessment; and 39 (95% CI 37, 40) for physician global assessment. Estimates were consistent across diseases and countries (for subgroups ≥20 patients). Conclusion This work allows for promoting the use of values of MCII (15 of 100 for absolute improvement, 20% for relative improvement) and PASS (40 of 100) in reporting the results of trials of any of the 5 involved rheumatic diseases with pain, patient global assessment, physical function, or physician global assessment used as outcome criteria. To estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5 rheumatic diseases and 7 countries. We conducted a multinational (Australia, France, Italy, Lebanon, Morocco, Spain, and The Netherlands) 4-week cohort study involving 1,532 patients who were prescribed nonsteroidal antiinflammatory drugs for ankylosing spondylitis, chronic back pain, hand osteoarthritis, hip and/or knee osteoarthritis, or rheumatoid arthritis. The MCII and PASS values were estimated with the 75th percentile approach for 4 generic outcomes: pain, patient global assessment, functional disability, and physician global assessment, all normalized to a 0-100 score. For the whole sample, the estimated MCII values for absolute change at 4 weeks were -17 (95% confidence interval [95% CI] -18, -15) for pain; -15 (95% CI -16, -14) for patient global assessment; -12 (95% CI -13, -11) for functional disability assessment; and -14 (95% CI -15, -14) for physician global assessment. For the whole sample, the estimated PASS values were 42 (95% CI 40, 44) for pain; 43 (95% CI 41, 45) for patient global assessment; 43 (95% CI 41, 44) for functional disability assessment; and 39 (95% CI 37, 40) for physician global assessment. Estimates were consistent across diseases and countries (for subgroups ≥20 patients). This work allows for promoting the use of values of MCII (15 of 100 for absolute improvement, 20% for relative improvement) and PASS (40 of 100) in reporting the results of trials of any of the 5 involved rheumatic diseases with pain, patient global assessment, physical function, or physician global assessment used as outcome criteria. OBJECTIVETo estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5 rheumatic diseases and 7 countries.METHODSWe conducted a multinational (Australia, France, Italy, Lebanon, Morocco, Spain, and The Netherlands) 4-week cohort study involving 1,532 patients who were prescribed nonsteroidal antiinflammatory drugs for ankylosing spondylitis, chronic back pain, hand osteoarthritis, hip and/or knee osteoarthritis, or rheumatoid arthritis. The MCII and PASS values were estimated with the 75th percentile approach for 4 generic outcomes: pain, patient global assessment, functional disability, and physician global assessment, all normalized to a 0-100 score.RESULTSFor the whole sample, the estimated MCII values for absolute change at 4 weeks were -17 (95% confidence interval [95% CI] -18, -15) for pain; -15 (95% CI -16, -14) for patient global assessment; -12 (95% CI -13, -11) for functional disability assessment; and -14 (95% CI -15, -14) for physician global assessment. For the whole sample, the estimated PASS values were 42 (95% CI 40, 44) for pain; 43 (95% CI 41, 45) for patient global assessment; 43 (95% CI 41, 44) for functional disability assessment; and 39 (95% CI 37, 40) for physician global assessment. Estimates were consistent across diseases and countries (for subgroups ≥20 patients).CONCLUSIONThis work allows for promoting the use of values of MCII (15 of 100 for absolute improvement, 20% for relative improvement) and PASS (40 of 100) in reporting the results of trials of any of the 5 involved rheumatic diseases with pain, patient global assessment, physical function, or physician global assessment used as outcome criteria. |
Author | Martin‐Mola, E. Ravaud, P. Logeart, I. Felson, D. T. Tubach, F. Hajjaj‐Hassouni, N. van der Heijde, D. Bombardier, C. Bellamy, N. Awada, H. van de Laar, M. Hochberg, M. Matucci‐Cerinic, M. Dougados, M. |
Author_xml | – sequence: 1 givenname: F. surname: Tubach fullname: Tubach, F. email: florence.tubach@bch.aphp.fr – sequence: 2 givenname: P. surname: Ravaud fullname: Ravaud, P. – sequence: 3 givenname: E. surname: Martin‐Mola fullname: Martin‐Mola, E. – sequence: 4 givenname: H. surname: Awada fullname: Awada, H. – sequence: 5 givenname: N. surname: Bellamy fullname: Bellamy, N. – sequence: 6 givenname: C. surname: Bombardier fullname: Bombardier, C. – sequence: 7 givenname: D. T. surname: Felson fullname: Felson, D. T. – sequence: 8 givenname: N. surname: Hajjaj‐Hassouni fullname: Hajjaj‐Hassouni, N. – sequence: 9 givenname: M. surname: Hochberg fullname: Hochberg, M. – sequence: 10 givenname: I. surname: Logeart fullname: Logeart, I. – sequence: 11 givenname: M. surname: Matucci‐Cerinic fullname: Matucci‐Cerinic, M. – sequence: 12 givenname: M. surname: van de Laar fullname: van de Laar, M. – sequence: 13 givenname: D. surname: van der Heijde fullname: van der Heijde, D. – sequence: 14 givenname: M. surname: Dougados fullname: Dougados, M. |
BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26674640$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/22674853$$D View this record in MEDLINE/PubMed |
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Keywords | Knee Knee osteoarthritis Lumbar spine Low back pain Diseases of the osteoarticular system Autoimmune disease Inflammatory joint disease Spine disease Spondylarthropathy Improvement Pain Dorsalgia Rachialgia Hip osteoarthritis Degenerative disease Ankylosing spondylitis Human Immunopathology Rheumatology Hand Hip Symptomatology Chronic Rheumatoid arthritis Arthropathy Dorsal spine Osteoarthritis |
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Notes | Dr. Hochberg has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott, Amgen, AstraZeneca, Bristol Myers Squibb, Covidien, Eli Lilly, EMD Serono, Merck, Genentech, VCB, Theralogix, and Teva Pharmaceuticals, and (more than $10,000 each) from Bioiberica, NicOx, and Pfizer. Dr. Ravaud has received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Merck, Sharp, & Dohme. Dr. Bombardier holds a Pfizer Research Chair and a Canada Research Chair in Knowledge Transfer for Musculoskeletal Care. Dr. Awada has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Ipsen and Novartis. Dr. van der Heijde has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott, Amgen, AstraZeneca, Bristol Myers Squibb, Centocor, Chugai, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Otsuka, Pfizer, Roche, Sanofi‐Aventis, Schering Plough, UCB, and Wyeth. Dr. Matucci‐Cerinic has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Bristol Myers Squibb, Pfizer, and Actelion. Dr. Dougados has received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Merck. Dr. Bombardier has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott Canada, AstraZeneca, BioGen, Pfizer, Merck (Schering), and Janssen (Merck), (more than $10,000) from Abbott International, and served on the advisory boards for Bristol Myers Squibb, Pfizer, Pfizer (Wyeth), Merck (Schering), Janssen (Merck), and Takeda. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
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PublicationTitle | Arthritis care & research (2010) |
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10.1002/art.22469 – ident: e_1_2_8_31_2 doi: 10.1002/art.1780340502 – ident: e_1_2_8_29_2 doi: 10.1002/art.1780270401 – ident: e_1_2_8_24_2 doi: 10.1016/j.pain.2005.12.021 – ident: e_1_2_8_17_2 doi: 10.1136/bmj.332.7549.1080 – volume: 24 start-page: 799 year: 1997 ident: e_1_2_8_3_2 article-title: Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis: consensus development at OMERACT III publication-title: J Rheumatol contributor: fullname: Bellamy N – ident: e_1_2_8_23_2 doi: 10.1002/art.22342 – ident: e_1_2_8_33_2 doi: 10.1002/art.1780230202 – ident: e_1_2_8_7_2 doi: 10.1016/S0895-4356(03)00044-1 |
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To estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5... To estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5 rheumatic... Abstract Objective To estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in... OBJECTIVETo estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5... |
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SubjectTerms | Adult Aged Arthritis, Rheumatoid - diagnosis Arthritis, Rheumatoid - psychology Arthritis, Rheumatoid - therapy Back Pain - diagnosis Back Pain - psychology Back Pain - therapy Biological and medical sciences Chronic Pain - diagnosis Chronic Pain - psychology Chronic Pain - therapy Cohort Studies Disability Evaluation Diseases of the osteoarticular system Diseases of the spine Female Humans Inflammatory joint diseases Internationality Male Medical sciences Middle Aged Osteoarthritis Osteoarthritis, Hip - diagnosis Osteoarthritis, Hip - psychology Osteoarthritis, Hip - therapy Osteoarthritis, Knee - diagnosis Osteoarthritis, Knee - psychology Osteoarthritis, Knee - therapy Patient Satisfaction - statistics & numerical data Prospective Studies Rheumatic Diseases - diagnosis Rheumatic Diseases - psychology Rheumatic Diseases - therapy Severity of Illness Index Spondylitis, Ankylosing - diagnosis Spondylitis, Ankylosing - psychology Spondylitis, Ankylosing - therapy Treatment Outcome |
Title | Minimum clinically important improvement and patient acceptable symptom state in pain and function in rheumatoid arthritis, ankylosing spondylitis, chronic back pain, hand osteoarthritis, and hip and knee osteoarthritis: Results from a prospective multinational study |
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